Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176748
Status:
COMPLETED
Last Update Posted:
2010-01-15
First Post:
2005-09-09
Brief Title:
Treatment for Patients With Metastatic Thyroid Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer Who Are Refractory to or Not Suitable Candidates for 131I Treatment
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to find out the good and bad effects of an investigational drug that is not approved for sale called AG-013736 Tumors need blood vessels in order to continue to grow and AG-013736 is thought to work by playing a role in preventing new blood vessels from growing We want to see if AG-013736 has any effect on your disease by making your tumor smaller and if so for how long We also want to test the safety the effect on your body of AG-013736 and to measure the amount of AG-013736 that gets into your blood AG-013736 has been given to over 140 patients with cancer on other studies
Detailed Description:
The American Cancer Society estimates that there will be about 23600 new cases of thyroid cancer 5960 in men and 17640 in women annually in the United States and about 1460 people 620 men and 840 women will die from this disease1 It is the most common malignancy of the endocrine system Depending upon type and stage thyroid cancer may be treated with surgery radioactive iodine 131I hormone treatment external radiation or chemotherapy
The systemic therapy of metastatic disease remains palliative until new agents are found that might afford a better prognosis Thyroid tumors are often vascular and a decrease in the number of blood vessels that supply the tumor may starve it of needed nutrients An approach to blocking the growth of blood vessels that supply the tumor is to inhibit the VEGF receptor tyrosine kinase VEGFR TK signaling pathway The VEGFR TK inhibitor SU011248 has produced 4 objective responses in 15 patients receiving the drug on Phase 1 studies2 AG-013736 is another VEGFR TK inhibitor Besides having potential anti-angiogenesis properties through VEGFR TK inhibition it also has additional potential antitumor through platelet derived growth factor receptor PDGFR TK inhibition
The systemic therapy of metastatic disease remains palliative until new agents are found that might afford a better prognosis Thyroid tumors are often vascular and a decrease in the number of blood vessels that supply the tumor may starve it of needed nutrients An approach to blocking the growth of blood vessels that supply the tumor is to inhibit the VEGF receptor tyrosine kinase VEGFR TK signaling pathway The VEGFR TK inhibitor SU011248 has produced 4 objective responses in 15 patients receiving the drug on Phase 1 studies2 AG-013736 is another VEGFR TK inhibitor Besides having potential anti-angiogenesis properties through VEGFR TK inhibition it also has additional potential antitumor through platelet derived growth factor receptor PDGFR TK inhibition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HUM 216 | None | None | None |